PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis
PREDICT
Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
1 other identifier
observational
200
1 country
19
Brief Summary
Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2013
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedApril 2, 2024
March 1, 2024
11.3 years
February 24, 2014
March 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion meeting the diagnosis of NTM disease
12 months intervals following study enrollment
Secondary Outcomes (5)
Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol
12 months intervals following study enrollment
Incidence and prevalence of NTM species/subspecies by geographical region
12 months intervals following study enrollment
Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site
12 months intervals following study enrollment
Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE
12 months intervals following study enrollment
Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)
12 months intervals following study enrollment
Study Arms (1)
CF patients
Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
Eligibility Criteria
Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
You may qualify if:
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
- Male or female participant ≥ 6 years of age at enrollment
- Diagnosis of CF consistent with the 2017 CFF Guidelines
- NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.
- Willing to discontinue chronic azithromycin use for the duration of the study
You may not qualify if:
- Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
- History of solid organ or hematological transplantation
- Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Cystic Fibrosis Foundationcollaborator
- Children's Hospital Coloradocollaborator
Study Sites (19)
CFF Pediatric Program, University of Alabama
Birmingham, Alabama, 35233, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
CFF Adult Program, Johns Hopkins University
Baltimore, Maryland, 21205, United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, United States
CFF Pediatric Program University of Michigan
Ann Arbor, Michigan, 48109, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
CFF Pediatric Program, Columbia University
New York, New York, 10032, United States
CFF Adult Program, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8558, United States
University of Vermont Medical Center
Burlington, Vermont, United States
CFF Pediatric Program Seattle Children's Hospital
Seattle, Washington, 98105, United States
CFF Adult Program, University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Martiniano SL, Caceres SM, Poch K, Rysavy NM, Lovell VK, Armantrout E, Jones M, Anthony M, Keck A, Nichols DP, Vandalfsen JM, Sagel SD, Wagner B, Xie J, Weaver K, Heltshe SL, Daley CL, Davidson RM, Nick JA; Investigators of the Cystic Fibrosis NTM Consortium. Prospective evaluation of nontuberculous mycobacteria disease in cystic fibrosis: The design of the PREDICT study. J Cyst Fibros. 2024 Jan;23(1):50-57. doi: 10.1016/j.jcf.2023.08.007. Epub 2023 Sep 4.
PMID: 37666709DERIVED
Biospecimen
Samples collected may include serum, sputum, whole blood, breath, urine, and NTM isolates.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry A Nick, MD
National Jewish Health
- PRINCIPAL INVESTIGATOR
Stacey Martiniano, MD
Children's Hospital Colorado
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 27, 2014
Study Start
December 1, 2013
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
April 2, 2024
Record last verified: 2024-03